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Certificates and go to Uniqa Shop
Certificates and go to Uniqa Shop
![Check Certificates and go to Uniqa Shop](https://uniqa.dental/wp-content/webp-express/webp-images/uploads/2023/09/cert_banner.png.webp)
Our Certificates
![ISO 13485:2016 Certificate for Uniqa Dental](https://uniqa.dental/wp-content/webp-express/webp-images/uploads/2023/10/cert1.jpg.webp)
ISO 13485:2016 Certificate for Uniqa Dental
This certificate is issued to confirm that the Quality Management System of Uniqa Dental company has been assessed and found to be in compliance with the requirements of ISO 13485:2016 for the specified scope of activities.
Scope of Certification: Development, production, and marketing of dental implants, dental abutments, dental instruments, and accessories.The certificate is valid until: October 25, 2024.
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Scope of Certification: Development, production, and marketing of dental implants, dental abutments, dental instruments, and accessories.The certificate is valid until: October 25, 2024.
![Uniqa Dental AMAR](https://uniqa.dental/wp-content/webp-express/webp-images/uploads/2023/10/cert3.jpg.webp)
Uniqa Dental AMAR
This document serves as confirmation of the registration and tax compliance of Uniqa Dental for medical components for dental implantation. The Uniqa Dental AMAR Certificate is issued by the Ministry of Health of Israel within the Department of Medical Equipment.The document allows the use of components for dental implantation according to the manufacturer's instructions. The permission is valid until October 21, 2024.
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Uniqa Dental FDA K180159
This document signifies the official approval granted by the Food and Drug Administration (FDA) for the sale and distribution of dental implants dedicated to the restoration of teeth in the United States. The certification is granted to Uniqa Dental, acknowledging their compliance with the regulatory requirements and adherence to quality and safety standards.
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Our Certificates of Analysis
Bioburden
This certificate confirms that ten product samples have undergone laboratory testing at the certified laboratory AMINOLAB LTD (Israel). The laboratory is accredited under ISO/IEC 17025 with standard operating procedures. The research results confirm that Uniqa Dental products can be used in the medical field for direct purposes without restrictions.
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LAL
This certificate confirms that Uniqa Dental implants have undergone laboratory testing at the certified laboratory AMINOLAB LTD (Israel). The laboratory is accredited under ISO/IEC 17025 with standard operating procedures. The research results confirm that toxin levels do not exceed threshold values, and the products can be used for medical purposes, including direct contact with the sterile environment of the body.
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SEM
This protocol contains the results of the implant surface analysis using scanning electron microscopy (SEM) supplemented with energy-dispersive X-ray spectroscopy (EDS). The implant sample was provided by the Israel Institute of Materials Production Technologies (IMT). The study analyzed the surface structure of the implant and verified the presence and chemical composition of impurities on the implant surface.
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XPS
This protocol contains the results of the investigation of the chemical composition and electronic state of the implant surfaces. The XPS/AEA analysis methodology was used, where XPS stands for X-ray photoelectron spectroscopy, and AEA stands for Auger electron spectroscopy. Both methods are based on measuring the energy of electrons emitted from the sample under the influence of X-ray or electron beams. The samples for the study were provided at the Ilse Katz Institute for Nanoscale Science and Technology.
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Total manufactured
IMPLANTS
0
MULTI-UNIT ABUTMENTS
0
ANGLED MULTI UNIT ABUTMENT
0
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Screw Retained Restoration + Dental Implant Digital CAD/CAM Trial Kit
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